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Beware of research studies

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ano

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I had my hip replaced about a month ago, and at that time my doctor brought up the possible option of participating in a research study. I wouldn't be surprised if he got a "finders" fee for recommending it.

The doctor claimed that I wouldn't be at any medical risk, and the biggest benefit would be that I'd have my own "nurse" at my side during the duration of the study. And you get paid a bit. I said that I would consider it.

About a week before surgery, they called me to see if I was interested. It was a pain study to test a drug that had been around for 15 years, but not used for this purpose. It was a non-steroidal pain reliever like Celebrex and Vioxx, but injected. The goal was to use this medicine after surgery to reduce morphine use. They have discovered that the more morphine people use after surgery, the longer they take to recover.

O.K. sounded good, so I traveled to the research center about 15 miles away, had a physical, they drew blood, I had an EKG, and I signed 16 pages of consent forms. I'd get $100 if I completed it, and $50 if I stopped it early. It sounded good, not much money, but a 24 hour "nurse!" I can stop it at any time.

When I checked into the hospital for surgery at 5:30am, this woman was waiting for me. She was in charge of the research program and would be "overseering" everything. She seemed nice and we chatted until they called me. It was time.

When I was lying on the stretcher before surgery I saw the woman speaking to the anesthesiologist, apparently telling him that I'm in this study and can't have any pain medicine in the cocktail. This was the FIRST I heard of this and it wasn't mentioned in the 16 page release. I wasn't happy.

So I wake up two hours later, no pain because below the waist is still numb. I'm moved to a common area because my room isn't ready, and my wife joins me. Another woman comes over to introduce herself. Apparently the first research woman had to leave for a planned reason, and this second woman would be taking over. She asked me if I had pain and i had none. I had to make this on a sheet of paper she had.

So about an hour goes by and my pain has risen from a 2 to a 5 to a 7. The research lady says they will start the study when I go to my room, which is expected soon. Several hours go by and no room and lots of pain. I should have stopped the thing there, but they keep telling I will have a room real soon. After hours of pain I went to the room, and was given the "research" drug.

They said I had a 50% of getting the study drug, a 25% chance of getting a similar but approved drug, and 25% change of a placebo. I waited 30 minutes for the drug to work, and if not I would be given morphine. It didn't work and I finally got morphine. In 5 minutes I was now pain free.

They gave me an injection of the "research" drug every 6 hours. Every hour or so they asked me my pain level and I didn't need more morphine for about 5 hours (which they say is much better than normal.)

So, the 24 hour "nurse" really turned out to be nursing students that were outside my room in 12 hour shifts. They did schoolwork and other homework. Sometimes they were down the hall, and my wife tells me one spent most of her time flirting with a male nurse.

I spoke with the regular hospital nurse, and she told me I was the first research patient she has ever had. Even worse, it seems there was very poor planning and communication between the research "nurse" and the hospital nurses in terms of my medicine and what the hospital could and couldn't give me. It didn't give me warm and fuzzies.

So the drug, seemed to be working because I only required one more morphine, BUT there was another problem. When they put the research drug in my IV it really burned my arm for several minutes. For the third shot, the hospital nurse did a great job at injecting and burning wasn't bad, but the forth shot at 24 hours really burned, despite the nurse trying to inject it slow.

On the 5th shot, it still burned, and I said that was it. I was done. The study was scheduled to go for 72 hours but I only lasted 30. As it turned out my pain wasn't much for the next 2 days, so I'm not convinced it did much. It only was claimed to work for 6 hours.

When I finished the research "nurse" told me that I was only the 9th person in this study and I went the longest of anyone before me.

I would NEVER EVER do this again. A few days after I returned home, I called the main research doctor to complain of the problems I had. He said, "no one ever has complained before." The research facility has been there 20 years and I guess it was all just me.

My complaints:
1) Never told in advance about the witholding of normal pain meds.
2) Being in lots of pain for at least 3 hours. They blame the hospital for the room delay.
3) Poor planning and bad or non-existent coordination with the hospital.
4) The nurse was more of a burden than a benefit. Many times my wife had to find the research person when the hospital wanted to do something they were interested in participating in.

There is more, but this is most of it. If they ask you to participate, REALLY think about it before you say yes. You'll be sorry. Its a shame because it didn't have to be like this. Just run VERY poorly. I'm thinking about complaining to the drug company with the research drug as well.
 
Wow, ano....THAT was interesting reading and very educational. I don't know if all research studies are like yours (hopefully NOT), but it certainly would make a person think twice about participating. This is too important a surgery to be messing with experiments!!
 
No way, Jose!
[Bonesmart.org] Beware of research studies
 
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